An investigation of your cattle operation located at 581 Airport Road, Irasbug, VT, conducted by representatives of the U.S. Food and Drug Administration (FDA) on October 18 and November 1, 2005, confirmed that you offered animals for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342 (a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug penicillin G procaine to become adulterated within the meaning of section 501 (a)(5) of the Act [21 U.S.C. 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C 360b]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On or about May 9, 2005, you sold or delivered for sale a dairy cow, identified with Sale Tag 5860 and back tag 7291, for slaughter as food to the [redacted] which was subsequently picked up by [redacted] that same day. On or about May 10, 2005, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.10 parts per million (PPM) of penicillin in the kidney tissue and the presence of 0.19 parts per million (PPM) of penicillin in the liver tissue. A tolerance of 0.05 PPM has been established for residues of penicillin in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations section 556.510 (21 C.F.R. 556.510). The presence of penicillin aboe the established tolerance level in edible tissues from this animal causes the food ,to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [(21 U.S.C. 342(a)(2)(C)(ii)] .

Also, on or about June 7, 2005, you sold or delivered for sale a dairy cow, identifi back tag I3IC9716 and ear tag 6070, for slaughter as food to the which was subsequently picked up by [redacted] that same day. On or about June 8, 2005, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.14 parts per million (PPM) of penicillin in the liver tissue. A tolerance of 0.05 PPM has been established for residues of penicillin in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations section 556.510 (21 C.F.R. 556.510). The presence of penicillin above the established tolerance level in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [(21 U.S .C. 342(a)(2)(C)(ii)].

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records and you lack an inventory sys determining the quantities of drugs used to medicate your animals. Specifically, not maintain an inventory of drugs purchased and used. Food from animals held such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342 (a)(4)].

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your loverall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory 'I action, such as seizure and/or injunction, without further notice.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen ,(15)working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed fifteen (15) working days, state the reason for the delay and the time frame within the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your reply should be directed to Karen N. Archdeacon, Compliance Officer, Flood and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions you can contact Ms. Archdeacon at the above phone number.